BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Absorbable Coronary Drug-Eluting Stent

    PMA: P150023 · Decision Jul 5, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Absorbable Coronary Drug-Eluting Stent
    Trade Name
    ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
    PMA Number
    P150023
    Device Class
    FDA Class 3
    Product Code
    PNY
    Generic Name
    Absorbable coronary drug-eluting stent
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    July 5, 2016
    Date Received
    July 1, 2015
    Expedited Review
    N
    Docket Number
    16M-1914

    Advisory Committee Statement

    Approval for the ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) System. This device is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions >=2.5 mm to <=3.75 mm in diameter in lesions <=24 mm in length.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PNY Absorbable Coronary Drug-Eluting Stent